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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K200546
Device Name ZeeroMED View
Applicant
O3 Enterprise Srl
Padriciano 99
Tieste,  IT 34149
Applicant Contact Andrea Poli
Correspondent
Sigma Biomedical
7600 NW 69th Ave.
Medley,  FL  33166
Correspondent Contact Jorge Millan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/03/2020
Decision Date 05/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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